SYNTHESIS OF BULK CHEMICALS & DRUGS FOR PRECLINICAL USE

大宗化学品的合成

• 批准号: 2467018
• 负责人: YESH Y SACHDEVA
• 金额: $ 92.18万
• 依托单位: PHARM-ECO
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-06-29 至 1999-06-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2467018
• 关键词: antiAIDS agent; antineoplastics; chemical registry /resource; drug design /synthesis /production; drug quality /standard

The Pharmaceuticals Resources Branch (PRB) of the Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment, Diagnosis and Chemotherapy (DCTDC) of the National Cancer Institute has primary responsibility for the production of a variety of compounds as bulk pharmaceuticals for use in both clinical and preclinical evaluations as potential anti-AIDS agents and anticancer agents. The PRB works closely with the DTP screening group to prepare larger quantities of drug candidates for in vivo evaluation and for the preparation of derivatives of drug candidates with improved physical properties, such as improved solubility or better pharmacokinetic properties, through the use of pro-drugs or other selected chemical derivatives. As part of this process, the PRB may undertake the development of existing or new, more efficient, chemical processes, procedures, and techniques for the preparation of those compounds of interest. Once identified as a potential drug candidate for anti-AIDS or anticancer treatment, the PRB undertakes the scale-up preparation of varying amounts of compound, based on the immediate needs of the program. The amounts may range from milligram quantities to multi-kilogram quantities, depending upon the stage of development of the compound and its biological potency. Once accepted for human clinical trials, the PRB is responsible for the preparation of clinical materials that meet the FDA requirements for Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) drug production. As such the procedures developed by PRB will define the purity standards and criteria for the clinical bulk pharmaceutical based on those produced during the scale-up process. The purpose of this project is to obtain contractors who have the equipment and expertise to conduct organic synthesis and purification of potential anti-AIDS and anticancer drug candidates in quantities up to multi-kilogram amounts. Further, they must be capable of production under GMP and GLP conditions when needed. They will be called upon to procure, purity (if necessary) and characterize substances from suitable sources; perform preliminary stability, solubility, and analytical studies on the products; and prepare analytical reference standards, and novel derivatives as needed by the program.

药品资源部(PRB) 癌症治疗、诊断科治疗计划(DTP) 和化疗(DCTDC)的国家癌症研究所有初级 作为散装生产各种化合物的责任 用于临床和临床前评价的药物，如 潜在的抗艾滋病药物和抗癌药物。 公共关系科与DTP筛查小组密切合作，准备更大规模的 用于体内评价和治疗的候选药物的数量 物理性能改善的候选药物衍生物的制备 性质，如更好的溶解性或更好的药代动力学 性能，通过使用前体药物或其他选定的化学品 衍生品。作为这一过程的一部分，公共关系科可进行 开发现有的或新的、更有效的化学工艺， 用于制备这些化合物的程序和技术 利息。 曾被确定为潜在的抗艾滋病或抗癌候选药物 在治疗方面，公共关系科承担不同数量的扩大准备工作 复合，根据方案的迫切需要。有关金额可 从毫克量到几千克量不等，具体取决于 根据化合物的发展阶段及其生物效力。 一旦被接受用于人体临床试验，PRB负责 符合FDA要求的临床材料的制备 药品生产规范(GMP)和良好实验室规范(GLP) 制作。因此，公共关系科制定的程序将定义 临床原料药的纯度标准和标准 关于在放大过程中产生的那些。 该项目的目的是获得具有 进行有机合成和提纯的设备和专业知识 潜在的抗艾滋病和抗癌药物候选数量高达 几千克的量。此外，它们必须能够在以下条件下生产 需要时的GMP和GLP条件。他们将被召唤去获取， 纯度(如有必要)和来自适当来源的物质的特征； 对以下物质进行初步稳定性、溶解性和分析研究 产品；并准备分析参考标准，并新颖 根据计划需要的衍生品。